Sustaining Senior Design Assurance Engineer

1 Month ago • 3-5 Years • $87,000 PA - $155,904 PA

Job Summary

Job Description

The Sustaining Senior Design Assurance Engineer will provide quality engineering support and leadership for products from launch and stabilization through concept, design, and development, as well as commercially launched products. The role involves leading and supporting the development of product requirements, design verification strategies, and risk management. Responsibilities include participating in design reviews, managing risk, investigating product issues, and recommending preventive actions. Monitoring product issues, using quality tools for problem-solving, and maintaining knowledge of regulatory requirements are also key aspects of the job.
Must have:
  • 3+ years of experience with electrical engineering principles.
  • Experience in a regulated industry with knowledge of medical device requirements.
  • Bachelor's or Master's degree in Engineering.
Perks:
  • Generous PTO
  • 401k (up to 7% match)
  • HSA (with company contribution)
  • Stock purchase plan
  • Education reimbursement

Job Details

Job Title

Sustaining Senior Design Assurance Engineer

Job Description

We’re looking for a highly qualified Senior Design Assurance Engineer (sustaining) to join our San Diego team.

Your role:

  • Provide quality engineering support and leadership for products which includes launch and stabilization through concept, design, and development as well as representing and providing quality engineering support on commercially launched products through sustaining initiatives (design, supplier, obsolescence changes).  Lead and support the development/update of product requirements, design verification strategies, design validation strategies and update of design trace matrices/DHF files in support of product design changes.

  • Participate in design reviews to ensure all pre-defined requirements have been met.  Lead the risk management process and on-going maintenance of the risk management file (Risk Management Plan, FMEAs, Hazard Analysis, Risk Management Report).

  • Ability to perform risk assessments for product changes (design, supplier, obsolescence) and update of the risk documentation as necessary.  Lead the investigation of complex product issues (CAPAs, NCRs, Issue Impact Assessments) and recommend appropriate preventive/corrective actions.

  • Monitoring/trending product issues/complaints and initiating appropriate quality planning principles to resolve such issues.  Ability to use quality tools for effective problem solving (5 Why, Pareto, Fish bone, FMEA).  Maintain knowledge of current regulatory requirements, applicable laws and standards as well as internal quality system requirements.

  • Represent Philips as appropriate in FDA, notified body, internal and external audits.  Mentoring of junior staff including training, motivating and monitoring.

You're the right fit if:

  • You’ve acquired 3+ years of experience with electrical engineering principles with respect to systems, sub-systems and components. Ability to thoroughly understand complex hardware systems and how the systems work/operate.

  • Your skills include experience working in a regulated industry with full working knowledge of 21 CFR 820, ISO 13485 and ISO14971 medical device/safety requirements.  Strong knowledge/experience with CAPAs, NCRs and product issue impact assessments through the corrections and removals evaluation process.

  • You have a bachelor's degree in engineering (electrical engineering, bio-medical engineering) with a minimum of 5 years of experience or a master's degree in engineering (electrical engineering, bio-medical engineering) with a minimum of 3 years of experience.

  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

  • You’re a self-motivated individual and a self-starter who can work independently with minimal supervision.  Strong interpersonal skills, organizational skills and project management skills are essential.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

Philips Transparency Details

The pay range for this position in California, Massachusetts and Washington is $97,440 to $155,904 annually.

The pay range for this position in Minnesota is $91,350 to $146,160 annually.

The pay range for this position in Florida, Colorado, and Tennessee is $87,000 to $139,200 annually.

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.   

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered.  Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more.  Details about our benefits can be found here

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. 

Additional Information

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position.  For this position, you must reside in or within commuting distance to San Diego, CA., Cambridge, MA., Bothell, WA., Nashville, TN., Colorado Springs, CO., Plymouth, MN., or Orlando, FL. or Freemont, CA. USA

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates.  Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

Similar Jobs

Coherent corp. - Production Maintenance Technician

Coherent corp.

Philadelphia, Pennsylvania, United States (On-Site)
1 Month ago
Visa - Implementation Analyst

Visa

Almaty, Almaty Region, Kazakhstan (Hybrid)
3 Months ago
Sportskeeda - SEO Intern

Sportskeeda

(Remote)
1 Month ago
Ion - Senior UI Designer - Italy

Ion

Pisa, Tuscany, Italy (On-Site)
8 Months ago
Ziff Davis - Software Engineer II

Ziff Davis

Helsinki, Uusimaa, Finland (On-Site)
1 Month ago

Get notifed when new similar jobs are uploaded

Similar Skill Jobs

Doola - Video Editor (Philippines / Bangalore)

Doola

Philippines (Remote)
8 Months ago
Springer Group - Product Owner, Editorial Excellence

Springer Group

Dordrecht, South Holland, Netherlands (Hybrid)
1 Month ago
Design match - Web Designer (Ecommerce)

Design match

(Remote)
5 Months ago
Nintendo - UI Artist III

Nintendo

Redmond, Washington, United States (Hybrid)
5 Months ago
Accenture - Business Advisory Associate

Accenture

Navi Mumbai, Maharashtra, India (On-Site)
1 Month ago
Garena - KOL & Community Manager (Philippines-Based)

Garena

(Remote)
2 Months ago
Framestore - FREELANCE: CG - LOS ANGELES

Framestore

Los Angeles, California, United States (On-Site)
11 Months ago
Crowd Strick - Ukrainian Corporate Account Executive, Territory

Crowd Strick

(Remote)
1 Month ago
bytedance - Corporate Secretary, South Asia (12-month Contract)

bytedance

Gurugram, Haryana, India (On-Site)
3 Months ago
Barracuda Networks Inc - Sales Renewals Representative

Barracuda Networks Inc

Campbell, California, United States (Hybrid)
3 Months ago

Get notifed when new similar jobs are uploaded

Jobs in San Diego, California, United States

Zinnia - Lead Product Manager (AI and Data Analytics)

Zinnia

Bridgewater, New Jersey, United States (Hybrid)
2 Months ago
Cadence - Sr Account Executive

Cadence

San Jose, California, United States (On-Site)
1 Month ago
Marsh McLennan - Insurance Operations Specialist III

Marsh McLennan

Austin, Texas, United States (Hybrid)
1 Month ago
Coherent corp. - Senior Buyer / Planner

Coherent corp.

Bloomfield, Connecticut, United States (Hybrid)
1 Month ago
Nintendo - Senior Localization Editor (Portuguese)

Nintendo

Redmond, Washington, United States (Hybrid)
6 Months ago
Uniswap Labs - PhD Research Fellow

Uniswap Labs

New York, United States (On-Site)
1 Month ago
CD PROJEKT RED - Expert Technical Artist - Graphics

CD PROJEKT RED

Boston, Massachusetts, United States (Remote)
1 Month ago
Yodlee - Governance Risk Management and Compliance Manager

Yodlee

United States (Remote)
2 Months ago
LLNL - Intelligence Analyst (Senior-Level)

LLNL

Livermore, California, United States (On-Site)
3 Weeks ago
Synechron - Functional QA Tester

Synechron

Jersey City, New Jersey, United States (On-Site)
4 Weeks ago

Get notifed when new similar jobs are uploaded

Similar Category Jobs

Looks like we're out of matches

Set up an alert and we'll send you similar jobs the moment they appear!

About The Company

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.Together, we deliver better care for more people because we believe that every human matters.

Valhalla, New York, United States (On-Site)

New York, United States (On-Site)

Extrema, State Of Minas Gerais, Brazil (On-Site)

Denver, Colorado, United States (On-Site)

Cleveland, Ohio, United States (On-Site)

Cambridge, Massachusetts, United States (On-Site)

Cambridge, Massachusetts, United States (On-Site)

Cambridge, Massachusetts, United States (On-Site)

View All Jobs

Get notified when new jobs are added by Philips

Level Up Your Career in Game Development!

Transform Your Passion into Profession with Our Comprehensive Courses for Aspiring Game Developers.

Job Common Plug